Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: HOE901-U300 (new formulation of insulin glargine)
- Registration Number
- NCT01499095
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus
Secondary Objective:
* To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia
- Detailed Description
The maximum study duration was up to approximately 58 weeks per participants, consisting of:
* up to 2 week screening period
* 6-month comparative efficacy and safety treatment period
* 6-month comparative safety extension period
* 4-week safety follow-up period in a subset of participants
* a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 811
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HOE901-U300 HOE901-U300 (new formulation of insulin glargine) - Lantus Lantus (Insulin glargine) -
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline to Month 6 Endpoint Baseline, Month 6 Only measurements performed before initiation of rescue therapy were considered in the analysis.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint Week 9 Up to Month 6 Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (\<=) 3.9 mmol/L (70 milligram per deciliter \[mg/dL\]). Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint Baseline, Month 6 Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint Baseline, Month 6 Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of co-efficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Percentage of Participants With HbA1c <7% at Month 6 Endpoint Month 6 Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint Baseline, Month 6 Only measurements performed before initiation of rescue therapy were considered in the analysis.
Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint Month 6 Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint Baseline, Month 6 Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint Baseline, Month 6 Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint Baseline, Month 6 DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 Up to Month 12 Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of \<=3.9 mmol/L \[70 mg/dL\]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level \<=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level \<=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level \>3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose \<=3.9 mmol/L).
Trial Locations
- Locations (213)
Investigational Site Number 840074
🇺🇸Anaheim, California, United States
Investigational Site Number 840513
🇺🇸Pembroke Pines, Florida, United States
Investigational Site Number 840050
🇺🇸Idaho Falls, Idaho, United States
Investigational Site Number 840023
🇺🇸Southfield, Michigan, United States
Investigational Site Number 840042
🇺🇸Knoxville, Tennessee, United States
Investigational Site Number 840068
🇺🇸Tempe, Arizona, United States
Investigational Site Number 840149
🇺🇸Chandler, Arizona, United States
Investigational Site Number 840093
🇺🇸Glendale, Arizona, United States
Investigational Site Number 840018
🇺🇸Mountain Home, Arkansas, United States
Investigational Site Number 840047
🇺🇸Wilmington, North Carolina, United States
Investigational Site Number 840076
🇺🇸Greer, South Carolina, United States
Investigational Site Number 840502
🇺🇸Butte, Montana, United States
Investigational Site Number 840080
🇺🇸Medford, Oregon, United States
Investigational Site Number 840057
🇺🇸La Jolla, California, United States
Investigational Site Number 840140
🇺🇸Calabash, North Carolina, United States
Investigational Site Number 840509
🇺🇸Bell Gardens, California, United States
Investigational Site Number 840028
🇺🇸Bristol, Tennessee, United States
Investigational Site Number 840526
🇺🇸Chesterfield, Missouri, United States
Investigational Site Number 840158
🇺🇸Biloxi, Mississippi, United States
Investigational Site Number 840037
🇺🇸Orem, Utah, United States
Investigational Site Number 840084
🇺🇸Fremont, Nebraska, United States
Investigational Site Number 840087
🇺🇸Toms River, New Jersey, United States
Investigational Site Number 840139
🇺🇸Hickory, North Carolina, United States
Investigational Site Number 840145
🇺🇸Toms River, New Jersey, United States
Investigational Site Number 840153
🇺🇸Hickory, North Carolina, United States
Investigational Site Number 840065
🇺🇸Fargo, North Dakota, United States
Investigational Site Number 124004
🇨🇦Mirabel, Canada
Investigational Site Number 152001
🇨🇱Santiago, Chile
Investigational Site Number 840134
🇺🇸Winchester, Virginia, United States
Investigational Site Number 250001
🇫🇷La Rochelle Cedex, France
Investigational Site Number 250003
🇫🇷Venissieux, France
Investigational Site Number 124002
🇨🇦Red Deer, Canada
Investigational Site Number 124019
🇨🇦Chilliwack, Canada
Investigational Site Number 840009
🇺🇸Draper, Utah, United States
Investigational Site Number 840032
🇺🇸Chesapeake, Virginia, United States
Investigational Site Number 124024
🇨🇦Beamsville, Canada
Investigational Site Number 124026
🇨🇦Mississauga, Canada
Investigational Site Number 484009
🇲🇽Acapulco, Mexico
Investigational Site Number 276003
🇩🇪Neumünster, Germany
Investigational Site Number 643016
🇷🇺Ufa, Russian Federation
Investigational Site Number 643002
🇷🇺Saratov, Russian Federation
Investigational Site Number 643014
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 710014
🇿🇦Bloemfontein, South Africa
Investigational Site Number 643013
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 724001
🇪🇸Sabadell, Spain
Investigational Site Number 710005
🇿🇦Pretoria, South Africa
Investigational Site Number 710012
🇿🇦Somerset West, South Africa
Investigational Site Number 840031
🇺🇸Rockville, Maryland, United States
Investigational Site Number 840527
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840097
🇺🇸Columbus, Ohio, United States
Investigational Site Number 840026
🇺🇸Los Angeles, California, United States
Investigational Site Number 840004
🇺🇸San Diego, California, United States
Investigational Site Number 840199
🇺🇸Chicago, Illinois, United States
Investigational Site Number 840162
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840034
🇺🇸Baltimore, Maryland, United States
Investigational Site Number 840079
🇺🇸Houston, Texas, United States
Investigational Site Number 840514
🇺🇸Houston, Texas, United States
Investigational Site Number 840525
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840161
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840150
🇺🇸Baltimore, Maryland, United States
Investigational Site Number 840081
🇺🇸Minneapolis, Minnesota, United States
Investigational Site Number 840510
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 840069
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 152014
🇨🇱Osorno, Chile
Investigational Site Number 152012
🇨🇱Rancagua, Chile
Investigational Site Number 152004
🇨🇱Santiago, Chile
Investigational Site Number 642008
🇷🇴Bacau, Romania
Investigational Site Number 152002
🇨🇱Santiago, Chile
Investigational Site Number 152009
🇨🇱Valdivia, Chile
Investigational Site Number 642006
🇷🇴Deva, Romania
Investigational Site Number 152013
🇨🇱Santiago, Chile
Investigational Site Number 152010
🇨🇱Santiago, Chile
Investigational Site Number 152006
🇨🇱Temuco, Chile
Investigational Site Number 484006
🇲🇽Mexico City, Mexico
Investigational Site Number 484001
🇲🇽Monterrey, Mexico
Investigational Site Number 642013
🇷🇴Oradea, Romania
Investigational Site Number 620007
🇵🇹Matosinhos, Portugal
Investigational Site Number 642011
🇷🇴Hunedoara, Romania
Investigational Site Number 124010
🇨🇦Victoria, Canada
Investigational Site Number 124020
🇨🇦Calgary, Canada
Investigational Site Number 840099
🇺🇸Palm Springs, California, United States
Investigational Site Number 840056
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840519
🇺🇸Corpus Christi, Texas, United States
Investigational Site Number 840135
🇺🇸Summit, New Jersey, United States
Investigational Site Number 840005
🇺🇸Uniontown, Pennsylvania, United States
Investigational Site Number 840108
🇺🇸Maumee, Ohio, United States
Investigational Site Number 840007
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 840113
🇺🇸Dayton, Ohio, United States
Investigational Site Number 840148
🇺🇸Tipton, Pennsylvania, United States
Investigational Site Number 840504
🇺🇸Eugene, Oregon, United States
Investigational Site Number 840038
🇺🇸Chattanooga, Tennessee, United States
Investigational Site Number 840503
🇺🇸Simpsonville, South Carolina, United States
Investigational Site Number 840048
🇺🇸Rapid City, South Dakota, United States
Investigational Site Number 840033
🇺🇸Memphis, Tennessee, United States
Investigational Site Number 840160
🇺🇸Memphis, Tennessee, United States
Investigational Site Number 840040
🇺🇸Norfolk, Virginia, United States
Investigational Site Number 840001
🇺🇸Dallas, Texas, United States
Investigational Site Number 840159
🇺🇸Dallas, Texas, United States
Investigational Site Number 840122
🇺🇸Walla Walla, Washington, United States
Investigational Site Number 840115
🇺🇸Dallas, Texas, United States
Investigational Site Number 124016
🇨🇦Edmonton, Canada
Investigational Site Number 840072
🇺🇸Williamsburg, Virginia, United States
Investigational Site Number 840523
🇺🇸Olympia, Washington, United States
Investigational Site Number 348001
🇭🇺Makó, Hungary
Investigational Site Number 348008
🇭🇺Mosonmagyaróvár, Hungary
Investigational Site Number 840085
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 840110
🇺🇸Sun City, Arizona, United States
Investigational Site Number 840015
🇺🇸Hot Springs, Arkansas, United States
Investigational Site Number 840114
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 840027
🇺🇸Searcy, Arkansas, United States
Investigational Site Number 840014
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 840003
🇺🇸La Mesa, California, United States
Investigational Site Number 840060
🇺🇸Greenbrae, California, United States
Investigational Site Number 840090
🇺🇸Mission Hills, California, United States
Investigational Site Number 840518
🇺🇸Brandon, Florida, United States
Investigational Site Number 840104
🇺🇸Colorado Springs, Colorado, United States
Investigational Site Number 840124
🇺🇸Santa Barbara, California, United States
Investigational Site Number 840128
🇺🇸Colorado Springs, Colorado, United States
Investigational Site Number 840012
🇺🇸Tustin, California, United States
Investigational Site Number 840049
🇺🇸Daytona Beach, Florida, United States
Investigational Site Number 840008
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840025
🇺🇸New Port Richey, Florida, United States
Investigational Site Number 840011
🇺🇸Ocoee, Florida, United States
Investigational Site Number 840520
🇺🇸Miami, Florida, United States
Investigational Site Number 840141
🇺🇸Palm Harbor, Florida, United States
Investigational Site Number 840107
🇺🇸Nampa, Idaho, United States
Investigational Site Number 840528
🇺🇸Columbus, Georgia, United States
Investigational Site Number 840077
🇺🇸Avon, Indiana, United States
Investigational Site Number 840021
🇺🇸McHenry, Illinois, United States
Investigational Site Number 840020
🇺🇸Springfield, Illinois, United States
Investigational Site Number 840045
🇺🇸Avon, Indiana, United States
Investigational Site Number 840088
🇺🇸Avon, Indiana, United States
Investigational Site Number 840089
🇺🇸Avon, Indiana, United States
Investigational Site Number 840091
🇺🇸Avon, Indiana, United States
Investigational Site Number 840130
🇺🇸Evansville, Indiana, United States
Investigational Site Number 840041
🇺🇸Paducah, Kentucky, United States
Investigational Site Number 840142
🇺🇸Lafayette, Indiana, United States
Investigational Site Number 840064
🇺🇸Dearborn, Michigan, United States
Investigational Site Number 840066
🇺🇸Eagan, Minnesota, United States
Investigational Site Number 840094
🇺🇸Flint, Michigan, United States
Investigational Site Number 124018
🇨🇦Coquitlam, Canada
Investigational Site Number 124025
🇨🇦Burlington, Canada
Investigational Site Number 124014
🇨🇦Hamilton, Canada
Investigational Site Number 124011
🇨🇦Toronto, Canada
Investigational Site Number 124013
🇨🇦Sherbrooke, Canada
Investigational Site Number 124022
🇨🇦Winnipeg, Canada
Investigational Site Number 152005
🇨🇱Santiago, Chile
Investigational Site Number 152003
🇨🇱Santiago, Chile
Investigational Site Number 152007
🇨🇱Santiago, Chile
Investigational Site Number 250005
🇫🇷Mantes La Jolie, France
Investigational Site Number 246001
🇫🇮Helsinki, Finland
Investigational Site Number 250004
🇫🇷Le Creusot, France
Investigational Site Number 250002
🇫🇷Nantes, France
Investigational Site Number 276004
🇩🇪Künzing, Germany
Investigational Site Number 276009
🇩🇪Pirna, Germany
Investigational Site Number 276008
🇩🇪Oberhausen, Germany
Investigational Site Number 250009
🇫🇷Strasbourg, France
Investigational Site Number 276007
🇩🇪Rehlingen-Siersburg, Germany
Investigational Site Number 276005
🇩🇪Wangen, Germany
Investigational Site Number 348006
🇭🇺Baja, Hungary
Investigational Site Number 348003
🇭🇺Budapest, Hungary
Investigational Site Number 348005
🇭🇺Budapest, Hungary
Investigational Site Number 348010
🇭🇺Budapest, Hungary
Investigational Site Number 348002
🇭🇺Eger, Hungary
Investigational Site Number 348004
🇭🇺Pápa, Hungary
Investigational Site Number 348009
🇭🇺Budapest, Hungary
Investigational Site Number 484008
🇲🇽Guadalajara, Mexico
Investigational Site Number 484007
🇲🇽Guadalajara, Mexico
Investigational Site Number 348007
🇭🇺Sátorlaljaújhely, Hungary
Investigational Site Number 642002
🇷🇴Bucuresti, Romania
Investigational Site Number 484010
🇲🇽Guadalajara, Mexico
Investigational Site Number 484003
🇲🇽Monterrey, Mexico
Investigational Site Number 484004
🇲🇽Pachuca, Mexico
Investigational Site Number 620004
🇵🇹Porto, Portugal
Investigational Site Number 642003
🇷🇴Bucuresti, Romania
Investigational Site Number 642009
🇷🇴Brasov, Romania
Investigational Site Number 642001
🇷🇴Bucuresti, Romania
Investigational Site Number 642012
🇷🇴Timisoara, Romania
Investigational Site Number 642014
🇷🇴Cluj Napoca, Romania
Investigational Site Number 642010
🇷🇴Ploiesti, Romania
Investigational Site Number 642004
🇷🇴Resita, Romania
Investigational Site Number 642015
🇷🇴Iasi, Romania
Investigational Site Number 642007
🇷🇴Targu Mures, Romania
Investigational Site Number 642005
🇷🇴Timisoara, Romania
Investigational Site Number 643010
🇷🇺Moscow, Russian Federation
Investigational Site Number 643009
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 643007
🇷🇺Moscow, Russian Federation
Investigational Site Number 643006
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 643004
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 643001
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 643011
🇷🇺Samara, Russian Federation
Investigational Site Number 643008
🇷🇺St. Petersburg, Russian Federation
Investigational Site Number 710006
🇿🇦Bloemfontein, South Africa
Investigational Site Number 643005
🇷🇺Voronezh, Russian Federation
Investigational Site Number 710007
🇿🇦Benoni, South Africa
Investigational Site Number 710010
🇿🇦Cape Town, South Africa
Investigational Site Number 710002
🇿🇦Boksburg, South Africa
Investigational Site Number 710003
🇿🇦Cape Town, South Africa
Investigational Site Number 710001
🇿🇦Johannesburg, South Africa
Investigational Site Number 724003
🇪🇸Malaga, Spain
Investigational Site Number 710008
🇿🇦Umkomaas, South Africa
Investigational Site Number 724005
🇪🇸Barcelona, Spain
Investigational Site Number 724006
🇪🇸Palma De Mallorca, Spain
Investigational Site Number 724002
🇪🇸Sevilla, Spain
Investigational Site Number 724004
🇪🇸Valancia, Spain
Investigational Site Number 840517
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840098
🇺🇸Denver, Colorado, United States
Investigational Site Number 840063
🇺🇸Ann Arbor, Michigan, United States
Investigational Site Number 840024
🇺🇸Winston-Salem, North Carolina, United States
Investigational Site Number 840022
🇺🇸Austin, Texas, United States
Investigational Site Number 840078
🇺🇸Austin, Texas, United States
Investigational Site Number 840095
🇺🇸Richmond, Virginia, United States
Investigational Site Number 840019
🇺🇸Milwaukee, Wisconsin, United States